Actively Recruiting
Cadonilimab Combined With Regorafenib as A Third-line Treatment in Patients With MSS CRLM
Led by Jin-hong Chen · Updated on 2024-07-30
44
Participants Needed
3
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single-arm, open-label, multicenter clinical study to evaluate the efficacy and safety of Candonilimab (AK104) combined with Regorafenib for the treatment of MSS colorectal liver metastasis. Candonilimab (AK104) is a humanized IgG1 bispecific antibody that targets PD-1 and CTLA-4.
CONDITIONS
Official Title
Cadonilimab Combined With Regorafenib as A Third-line Treatment in Patients With MSS CRLM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18 years old and < 75 years old
- ECOG Performance status score 0 or 1
- Histologically or cytologically confirmed adenocarcinoma of colon or rectum, with liver metastases, with or without extrahepatic metastases
- At least one measurable lesion as defined by RECIST version 1.1
- Progressed or intolerant to prior systemic therapy including fluoropyrimidines, irinotecan, oxaliplatin, bevacizumab and/or cetuximab/panitumumab (if RAS/RAF-wild-type)
- Known RAS and BRAF status
- Only patients with mismatch repair-proficient (pMMR)/microsatellite stable (MSS) status
- Adequate bone-marrow, liver, and renal function as assessed by laboratory tests within 7 days before starting treatment
- Patients of childbearing potential must use highly effective contraception during the study and for 120 days after last dose; females must have a negative pregnancy test within 3 days before first dose
- Able to understand and voluntarily sign informed consent
- No history of allergy to regorafenib, cadonilimab, or their components
You will not qualify if you...
- Women who are pregnant or breastfeeding
- Previous treatment with third-line regimens such as regorafenib, fruquintinib, trifluridine tipiracil, or immune checkpoint inhibitors including anti-PD-1, anti-PD-L1, anti-CTLA-4, or cellular immunotherapy
- Active autoimmune disease requiring systemic therapy within the past 2 years
- Active or prior history of inflammatory bowel disease such as Crohn's disease, ulcerative colitis, or chronic diarrhea
- Intervention, ablation, or radiotherapy for target lesion within previous 3 months
- Expected survival time less than 3 months
- Other malignant tumors within 3 years prior to enrollment except cured local tumors
- Severe psychological or psychiatric abnormalities
- History of severe arrhythmia, heart failure, severe ventilatory dysfunction, severe lung infection, or acute/chronic renal failure
- Concurrent enrollment in another clinical study unless observational or follow-up
- Any other clinically significant condition that may affect study participation or consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
2
Huashan Hospital
Shanghai, China, 200040
Actively Recruiting
3
Shanghai Tenth People's Hospital
Shanghai, China, 200072
Actively Recruiting
Research Team
J
Jinhong Chen, M.D
CONTACT
X
Xiangyu Wang, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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